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SternaLock® Blu Study & Product

History of Breastbone Closure

Each year in the United States, more than 700,000 people undergo
open-heart surgery via sternotomy. The sternotomy is the most commonly
used incision in heart surgery and is often referred to as “cracking
the chest.” This term refers to the breastbone (sternum) being cut
down the middle to allow for access to the heart. Unlike nearly every
other broken bone in the body, where metal plates and screws are used
to increase stability and promote bone healing, wrapping surgical
grade wire around the breastbone remains the primary technique for
holding the bone pieces together. In some instances, use of wires has
resulted in significant movement of the breastbone, 1, 2
and did not provide enough stability to support the bone.3
If this occurs, the bones may not heal back together and breastbone
complications such as infection, pain, or delayed bone healing may
occur.2, 3, 4, 5

Patient Education Materials

Information & Resources

What is rigid fixation?

Rigid fixation is the use of metal plates and screws to stabilize
fractured (broken) bones. If a broken bone cannot easily be casted,
such as the chest wall (also called the breastbone or sternum), rigid
fixation can be used to stabilize the bone fragments. Despite the
adoption of rigid fixation techniques in nearly every other bone, wire
closure remains the predominant method of sternal closure.6, 7,
8, 9

What is wire closure?

Traditional closure of the breastbone after open-heart surgery is
done by wrapping surgical grade stainless steel wire around and
through the bone halves and twisting them together to tighten; similar
to using a twist tie. Most surgeons who use wires will use multiple
and place them along the length of the sternum, in-between the ribs.

What is SternaLock Blu?

SternaLock Blu is a rigid fixation system of metal plates and
screws for use in sternal closure or sternal reconstruction
procedures. These plates and screws are intended to remain as
permanent fixtures that are not removed at a later time, unless
removal is necessary to re-access the heart, or other complications,
such as infection, arise. The plates and screws provide added
stability to the breastbone to help facilitate the breastbone
healing process after the bone is cut open for heart surgery. If
re-operation on your heart is necessary, the plates can be cut for
re-accessing the heart.10

What is the SternaLock Blu Study?

Rigid fixation is used to repair many bone fractures (bones broken
by injury), except a sternotomy, which is the sawing of the breastbone
in half to access the heart. As a leader in the musculoskeletal space,
Zimmer Biomet recognized an opportunity to expand the benefits of
rigid fixation to patients undergoing heart surgery.

The SternaLock Blu Study was designed by a team of heart surgeons
and health economic researchers, and compared outcomes following
sternal closure with SternaLock Blu or wire closure. A total of 236
patients (116 SternaLock Blu patients and 120 wire closure patients),
undergoing elective heart surgery were enrolled at 12 hospitals in the
United States. Patients were followed for six months to evaluate
healing, clinical outcomes and costs. 11, 12, 13

Although SternaLock Blu patients in the SternaLock Blu Study had
improved healing, zero breastbone complications, and spent fewer days
in rehab facilities, each patient’s results will vary based on their
risk factors.

These study results should not be construed as a substitute for
reviewing all of the actual study information with your surgeon or
physician. Only your surgeon can determine what closure method is
appropriate for you. All results that reference the SternaLock Blu
product are based on comparison to standard wire closure.11, 12

What are the risks associated with sternal closure? 10

To help minimize risk it is always important to follow your
surgeon’s sternal precautions. Sternal Precautions are preventative
guidelines provided by your surgeon to protect the breastbone and help
reduce breastbone complications.

While uncommon, breastbone complications can occur during and after
surgery. Breastbone complications include, but are not limited to:

Poor bone conditions can cause the plates or screws to
fracture

Incomplete bone healing or delayed healing

Allergic reaction to metal plates and screws

Decrease
in bone density

Shifting, bending, breaking or loosening of
plates and screws

Pain, discomfort, abnormal sensation, or
palpability due to the presence of the plates and screws

Inflammation around the fracture site and/or the plates or
screws

Poor healing of the bone

Decomposition of
bone

Improper selection of screws that are too long for the
thickness of the breastbone may protrude to the interior of the
chest.

Apart from the adverse effects there are always possible breastbone
complications of any surgical procedure such as, but not limited to,
infection, nerve or soft tissue (non-bone) damage, and pain which may
or may not be related to the implant. Implanted metal plates and
screws cannot replace normal healthy bone, and the device can break,
bend or be damaged as a result of stress, activity, load bearing or
inadequate bone healing. Continue with regular postoperative follow-up
examination as long as the plates and screws remain implanted.

You are not a candidate for sternal plating if you have the following:

SternaLock Blu patients
spent a total of 237 total fewer days in rehab hospitals or skilled
nursing facilities over 6 months. 705 total days for wire cerclage
patients (n=120) vs. 468 total days for SternaLock Blu patients
(n=116).

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The information herein is of a general nature and does not represent
or constitute medical advice or recommendations and is for
general education purposes only. The information includes descriptions
of a medical device that a thoracic (heart) surgeon may choose for
patients undergoing open-heart surgery.

Zimmer Biomet manufactures medical devices, including metal plates
and screws that may be used by your heart surgeon to hold together the
sternum (breastbone) after heart surgery. We do not practice medicine;
all questions regarding your medical condition must be directed to
your doctor(s).

Results with breastbone (sternum) plates and screws (rigid fixation)
will vary due to health, weight, activity and other variables. Not
all patients are candidates for this product and/or procedure. Only a
medical professional can determine the treatment appropriate for your
specific condition. Appropriate post-operative activities will differ
from patient to patient. Talk to your surgeon about whether rigid
fixation is right for you and the risks associated therewith,
including but not limited to the risks of infection, implant wear,
loosening, screw or plate breakage or incomplete bone healing. For a
complete list of risks associated with Zimmer Biomet’s rigid fixation
system, see Patient
Risk Information.

The SternaLock Blu study was funded by Zimmer Biomet.

All content herein is protected by copyright, trademarks and other
intellectual property rights, as applicable, owned by or licensed to
Zimmer Biomet or its affiliates unless otherwise indicated, and must
not be redistributed, duplicated or disclosed, in whole or in part,
without the express written consent of Zimmer Biomet.

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